P2 - Specialist, Commercial Quality and Regulatory Affairs

Danaher Corporation; Ciudad de México; On-site; MXN 450,000 - 600,000; Full time

Benefits offered by this job

Bonus eligibility

Health insurance

Pension plan

Paid time off

Job summary

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Specialist in Commercial Quality & Regulatory Affairs to support regulatory submissions, registrations, and post-market vigilance across LATAM from Mexico. The role is on-site and collaborates with sales, operations, and marketing to ensure regulatory compliance.

Ideal candidates have a degree in pharmacy, biology, biomedical engineering or chemistry and 2+ years in QA/regulatory roles, with knowledge of LATAM regulations and

Qualifications

• Bachelor's degree in pharmacy, biology, biomedical engineering or chemistry.
• 2+ years experience in quality assurance or regulatory affairs is preferred.
• Knowledge of Mexico and LATAM medical device regulations.
• English language (basic) to read documents and communicate with global teams.
• Experience with Quality Management Systems and GMP regulations.

Responsibilities

• Review and ensure the Quality Management System aligns with current sanitary regulations.
• Support quality audits with internal and external stakeholders (distributors, suppliers, regulatory bodies).
• Prepare technical dossiers to support product registrations and license renewals; assist with post-market vigilance.
• Evaluate design changes against regulatory requirements for license modifications; organize legal document databases for tenders.
• Provide technical documentation to support regulatory submissions for Sales Channel Partners.

Skills

Cross-functional teamwork

Analytical skills

Problem solving

Communication skills

Education

Bachelor's degree in pharmacy, biology, biomedical engineering or chemistry

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.

As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making-we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.

Learn about the Danaher Business System which makes everything possible.

Position Overview

The Specialist, Commercial Quality & Regulatory Affairs is responsible for supporting quality and regulatory processes such as product registration (New Registers, Amendments, Renewals, etc.), providing support to internal customer requirements, control of Legal and Technical Documents, conducting post market vigilance, performing administrative activities to support internal departments such as Tender, Operations and Marketing/Commercial, support with customer complaints, Quality Management System documentation and processes, internal and external quality audits for distributors and supplier audits.

This position reports to the Senior Manager, Commercial Quality Assurance LATAM and is part of Quality and Regulatory Team located in Mexico. The role will be an on-site role supporting Mexico, Puerto Rico/Caribbean, and other LATAM countries.

Primary Duties

• Review and ensure that the Quality Management System is up to date and aligned with current sanitary regulations.
• Support warehouse GMP oversight and processes improvements by taking part in the internal quality audits, external sanitary agency audits, suppliers and distributors audits.
• Prepare the technical dossiers to support registration for new products and license renewals and support Field Actions and other post market vigilance activities.
• Evaluate design changes against regulatory requirements to support the modifications in the registration license and organize a database of legal documents for tenders and internal regulatory processes.
• Support our Sales Channel Partners by providing the technical documentation for their regulatory submissions.

Essential Requirements

• Bachelor's degree in pharmacy, biology, biomedical engineering or chemistry.
• Experience >2 years in quality assurance (regulatory affairs experience is an added advantage).
• Knowledge in Mexico and other LATAM countries medical device regulations.
• English language (basic) to read documents and communicate with global organization.
• Experience with Quality Management Systems and GMP regulation.

Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role Not applicable for this role

Preferred Qualifications

• Ability to work in a cross-functional and teamwork environment.
• Communication, analytical, strong focus and problem-solving skills.
• Knowledge of in vitro diagnostics products and technologies.

Compensation & Benefits

This job is also eligible for bonus/incentive pay.

Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info .

We offer a comprehensive package of benefits including paid time off, medical/dental/life insurance and pension plan to eligible employees.

For more information, visit www.danaher.com.